Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

Not Applicable

Completed

Brief Summary: The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).

Recruitment & Eligibility

Inclusion Criteria

Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses
An Informed Consent Form signed by Subject or legally authorized representative
Male or infertile female
Able to comply with protocol requirements including following-up
Life expectancy > 2 years
Age > 21 years
Surgical candidate

Exclusion Criteria

Mycotic or ruptured aneurysm
Known concomitant thoracic aortic aneurysm which requires intervention
American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
Renal insufficiency defined or patient undergoing dialysis
New York Heart Association (NYHA) Functional Classification class IV
Dissected, heavily calcified, or heavily thrombosed landing zone(s)
Tortuous or stenotic iliac and/or femoral arteries
Participating in another investigational device or drug study within 1 year of treatment
Systemic infection which may increase the risk of endovascular graft infection
Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
Planned concomitant surgical procedure or major surgery within 30 days of treatment date
Known history of drug abuse
Known sensitivities or allergies to the device materials

Arm && Interventions

Group	Intervention	Description
GORE® EXCLUDER® Iliac Branch Endoprosthesis	GORE® EXCLUDER® Iliac Branch Endoprosthesis	GORE® EXCLUDER® Iliac Branch Endoprosthesis

Primary Outcome Measures

Name	Time	Method
Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC	Through 6 month follow-up visit	Freedom from all of the following: * Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) due to Type I/III endoleak as determined by Clinical Events Committee (CEC). * Complete loss of blood flow in leg of IBC or IIC as assessed by Core Laboratory * Reintervention on IBC or IIC to re-establish patency due to 60% occlusion or greater as determined by CEC.
Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair	30 days post-treatment	Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.

Secondary Outcome Measures

Name	Time	Method
Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC)	Through 6 month follow-up visit	Freedom from new onset buttock claudication arising from the side of the body treated with the Iliac Branch Component (IBC) and Internal Iliac Component (IIC).